Non-sterile compounding documentation for Ontario pharmacies
The Ontario College of Pharmacists adopted the Model Standards for Pharmacy Compounding of Non-Sterile Preparations and the accompanying guidance document in December 2017, with full implementation required by January 1, 2022. In February 2026 the College updated its assessment criteria, published a risk assessment template with a companion guide, and made a training course mandatory for new compounding supervisors and for current supervisors of pharmacies where the standards are not being met. We prepare the documents those criteria ask to see.
What changed in 2026
- Supervisor training. Any pharmacist or pharmacy technician assigned as a non-sterile compounding supervisor on or after February 5, 2026 must complete the College’s Non-Sterile Compounding Supervisor Training Course within three months of starting. Current supervisors of pharmacies found not to be meeting the standards have one month to complete it, a period the College’s operations advisors may extend. The course is free and ends with an exam, and new supervisors declare completion in the OCP portal.
- Assessment criteria. The Non-Sterile Preparations Assessment Criteria were updated in February 2026 and include completion of the supervisor course.
- Risk assessment resources. The College published a template, a companion guide and two worked examples. It states that use of the template is optional and that how a pharmacy documents its risk assessments is at the discretion of the non-sterile compounding supervisor.
The College has said the course was developed after operational assessment data showed that non-sterile compounding standards were not being fully met in some pharmacies.
What the criteria ask to see in writing
- A risk assessment for each preparation, reviewed at least every 12 months, with the decision algorithm applied and references consulted
- Policies and procedures for all compounding activities, readily retrievable and reviewed at least every 3 years
- A training and skills assessment program, documented for all compounding personnel
- A master formulation record for each preparation, with rationale and references, and complete compounding records
- Beyond-use dates assigned conservatively from the literature, not copied from a manufacturer’s expiry date
- A quality assurance program that periodically verifies and documents compounding activities
- For hazardous preparations: procedures for receiving, storage, cleaning, spills, exposure and waste, and certification records for the containment device and room
How we help Ontario pharmacies
We write the risk assessments, master formulation records and procedures listed above from your pharmacy’s own information, and we can lay out risk assessments in the College’s template if you prefer it. We do not replace the supervisor course, the supervisor’s judgment or the facility itself.
Common questions
Is the OCP risk assessment template mandatory?
No. The College states that its use is optional. What is required is a documented risk assessment for each preparation. How to complete the template
We were assessed before 2026. Do we need to redo anything?
Risk assessments must be reviewed at least every 12 months and procedures at least every 3 years, whenever your last assessment was. If your documents are older than that, the reviews are due, and it is worth checking them against the current criteria at the same time.
Our supervisor has taken the course. Why would we need help?
The course explains what is required. Someone still has to write an assessment and a record for every preparation, and the procedures for the pharmacy. That writing is what we do.